Patient-Reported Outcomes Assessment in the Practice Setting: Part 2: Setting Up an Outcomes Assessment Program in Your Practice

Maureen Hannley, PhD, is currently Chief of the Research Division of the Department of Otolaryngology and Communication Sciences at Medical College of Wisconsin and Research Consultant for the Triological Society. She formerly served as the Chief Research Officer of the American Academy of Otolaryngology- Head and Neck Surgery Foundation and has held positions at the National Institutes of Health, Stanford University Medical School, and Arizona State University.

Disease-specific outcomes measures in otolaryngology-head and neck surgery can be completed by your patients before and after treatment, enabling tracking of these important outcomes with a minimum of disruption to the normal practice routine (see ENT Today, January 2008, p. 8).

The first step in setting up such an outcomes assessment program in your practice-the very first step-is to make a decision and a commitment to begin. In today’s busy world, where the demands of a medical practice have become so complex, adding another project may seem out of the question. Therefore, your decision must derive from personal or practice-based motivations that you anticipate will be productive and satisfying. These may range from demonstrating to your patients that you are concerned about their overall health-related quality of life; gathering evidence of the effectiveness of a procedure for patient education, marketing, or reimbursement purposes; collecting data for your Triological Society thesis; and/or simply introducing an interesting new element into a practice that has grown predictable and unexciting. Enlisting the collaboration of one or more of your colleagues can often sustain the impetus and motivation through all phases of the project and ensure that critical details are not overlooked.

Next, decide what you want to investigate. Identify the condition or procedure in which you are interested and define the research question. These two critical steps will help you focus your efforts and allow you to design a project that has a beginning and an end, rather than simply having an open-ended data-collection machine that is mined for information at some point in the future. Selecting a topic may be as simple as pursuing an interesting association or effect that you’ve noticed clinically, or delving into a problem that has concerned or frustrated you. Maybe you’ve developed a new approach or modification to an existing procedure and want to evaluate its effectiveness in a more structured way. Ask yourself, What do I want to know? Why is it important to know this?

Once you have decided on a general topic, it is time to narrow it down to a specific question. Keep some fairly obvious pointers in mind at this stage:

• Ask a question that truly interests you and will sustain your interest through the long haul of collecting and analyzing the data.
• Ask a question that has clinical relevance, not just clinical application-does it have the big so-what?
• Ask a question in such a way that either a positive or negative answer will be of interest.
• Be specific in the way you construct your question.

A useful device for constructing the research question is to use the PICO approach. This acronym, common in evidence-based medicine, will remind you to construct a research question that specifies the Patient or Population of interest, the Intervention that will be applied, the Comparison population or intervention (if one is used; this is not always necessary); and the Outcome of interest. Do not neglect this step. It is a necessary one to focus your study, narrowing it to its essentials-the structure of the question will define the research design (cross-sectional, cohort, case-control) and hence the type of statistical analysis that will be necessary, and it will help you avoid the collection of extraneous data.